Field of the Invention
This invention relates to prostheses for replacing a human intervertebral disc and instruments for implanting such a prosthesis, and more particularly to an endplate for such a prosthesis having a domed surface for contacting an adjacent vertebra in a human spinal motion segment.
Background Art
The human spinal column achieves its remarkable combination of strong support and appropriate flexibility by reason of its structure comprising bony vertebrae separated by intervertebral discs of softer and flexible tissue that allow limited motion between adjacent vertebrae in flexion-extension, lateral bending, and torsion. Each individual flexible element of the spine, comprising a pair of adjacent vertebrae separated by an intervertebral disc, constitutes a spinal motion segment. The proper function of such a spinal motion segment requires the intervertebral disc to provide proper separation between the vertebrae while allowing sufficient relative motion in the median, coronal and transverse anatomical planes of the body. While each intervertebral disc typically performs its function effectively without conscious awareness, the disc and surrounding tissues are provided with ample innervation that informs the individual of any damage and/or malfunction by providing a pain signal.
The spinal regions most susceptible to painful pathology of the intervertebral disc are the cervical and lumbar regions. Such painful pathology is typically the result of some traumatic injury or age-related changes in the structure and function of the intervertebral disc.
The most common pathologic condition causing chronic low back pain and neck pain is degenerative disc disease (DDD), which is typically the result of age-related changes in the tissues constituting the intervertebral disc, with accompanying abnormalities, e.g., deformation, in the functional structures of the disc. Under such conditions, even normal movement between the adjacent vertebrae can cause pain, which may become chronic and sufficiently severe to result in significant disability. When non-invasive treatment fails to relieve chronic disabling back pain caused by such disease, recourse is had to surgical intervention. For some time, palliative surgical procedures such as disc excision, decompression, and/or spinal fusion have been performed to relieve intractable pain of patients with degenerative disc disease. More recently, artificial intervertebral disc prostheses have been developed, which have made it possible to replace a degenerated disc with such a prosthesis to achieve pain relief and restore anatomical function.
A number of factors must be considered in the design of an intervertebral disc prosthesis if a successful outcome of disc arthroplasty is to be expected. The prosthesis design must provide for proper positioning, correct alignment, congruent contact surface area, and immediate post-operative prosthetic stability within the disc space. In particular, the conformation of the vertebra-contacting surface of the prosthesis at the vertebra-prosthesis interface is of significant importance, particularly for post-operative stability of the prosthesis in the intervertebral space. Experience has shown that the clinical results of intervertebral disc arthroplasty are closely correlated to the proper initial positioning of the disc prosthesis in the disc space and subsequent maintenance thereof. For instance, if an implanted disc prosthesis does not maintain a stable position within the intervertebral space, the patient may experience post-operative accelerated disc degeneration in adjacent spinal motion segments, as well as formation of osteophytic growths on the vertebrae.
Another possible post-operative complication is subsidence of the disc prosthesis into an adjacent vertebra. Such instability is related to at least three factors: contact area between the prosthesis and the adjacent vertebral body, bone mineral density in the contacting surface of the vertebral body, and applied load. In particular, the effective prosthesis-vertebra contact area is affected by the variable curvature and irregular surface profile of the adjacent vertebra, both of which vary significantly from patient to patient, e.g., in the lumbosacral spine which is the site of many intervertebral disc arthroplasties.
The great variety of designs that have been proposed for the bone-contacting surface of intervertebral disc prostheses can be taken as evidence that an ideal design has yet to be achieved. Examples of such prostheses have included those with relatively flat vertebra-contacting surfaces, those with domed profiles, or those incorporating other specially configured shapes such as corrugated or serrated surfaces or protruded platforms.
Besides the general shape of the bone contacting surface, known intervertebral disc prostheses have incorporated additional structures to enhance the security of fixation to the vertebral bone. Some designs have incorporated provisions for fixation using screws driven either into the anterior or lateral sides of the adjacent vertebrae or into the vertebral endplate itself. The bone-contacting surfaces of other prostheses have been provided with spikes, keels, serrations, or the like, in order to provide stable fixation of the prosthesis.
However, certain drawbacks have been observed with the previously known intervertebral disc prostheses. For example, flat prosthetic endplate designs present problems of incongruous fit between the prosthetic endplate and the concave end surface of the vertebral body. Such a mismatch between the shapes can result in post-operative instability of the prosthesis in the disc space, in particular, settling of the prosthesis into the adjacent vertebra (subsidence). Designs that attempt to compensate for this mismatch by providing additional structures such as keel, spikes, and the like incur problems due to the greater distraction between vertebrae required for their implantation. Designs that employ screws placed into the endplates of the vertebrae encounter difficulties in implantation because of the limited working space and the relatively thin bone structures of the vertebral endplates, which do not provide a strong substrate for screw fixation.
Some intervertebral prostheses have incorporated endplates having dome-shaped surfaces for contact with the adjacent vertebral bodies. Both spherical domes and ellipsoidal domes have been employed. Ellipsoidal domes better approximate the planform of a vertebral body, and, when seated in a corresponding ellipsoidal seat reamed in the endplate of the vertebral body, provide a measure of torsional stability. However, preparation of such an ellipsoidal seat and proper alignment with the vertebrae can present some surgical difficulties. Spherical domes, having a circular planform, are more easily fitted to a prepared seat, but, by themselves, tend to provide less torsional stability.
Accordingly, a need has continued to exist for an endplate design that can alleviate the problems experienced in implantation of known intervertebral disc prostheses.